BEUDAMED
    96 results · 17ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Status: Terminated ×

    First SIGN SARS-CoV-2 Antigen Test

    FDA Recall
    Terminated ·WHPM Inc.·Product code QKP·March 4, 2022

    First SIGN SARS-CoV-2 Antigen Test

    FDA Enforcement
    Class II ·Terminated·WHPM Inc.·April 13, 2022

    Gynecare Thermachoice III Uterine Balloon Therapy System Ethicon, Inc. The GYNECARE THERMACHOICE¿ III Uterine Balloon Therapy (UBT) System is a thermal balloon ablation device intended to ablate the endometrial lining of the uterus in pre-menopausal women with menorrhagia (excessive uterine bleeding) due to benign causes for whom childbearing is complete.

    FDA Enforcement
    Class II ·Terminated·Ethicon, Inc.·January 13, 2016

    Gynecare Thermachoice III Uterine Balloon Therapy System Ethicon, Inc. The GYNECARE THERMACHOICE III Uterine Balloon Therapy (UBT) System is a thermal balloon ablation device intended to ablate the endometrial lining of the uterus in pre-menopausal women with menorrhagia (excessive uterine bleeding) due to benign causes for whom childbearing is complete.

    FDA Recall
    Terminated ·Ethicon, Inc. US·Product code PFJ·December 3, 2015

    Manifold Kit. Catalog Number K09-11867AP

    FDA Recall
    Terminated ·Merit Medical Systems, Inc.·Product code OJV·September 23, 2016

    Fluid Management Set. Catalog Number K08-MP5159A

    FDA Recall
    Terminated ·Merit Medical Systems, Inc.·Product code OJV·September 23, 2016

    Pressure Monitoring Kit (MeriTrans"). Catalog Number K11-00232G

    FDA Recall
    Terminated ·Merit Medical Systems, Inc.·Product code OJV·September 23, 2016

    Waste Management Kit. Catalog Number K10-04381AP

    FDA Recall
    Terminated ·Merit Medical Systems, Inc.·Product code OJV·September 23, 2016

    Procedure Kit. Catalog Numbers K12-04830B and K12-YP030A

    FDA Recall
    Terminated ·Merit Medical Systems, Inc.·Product code OJV·September 23, 2016

    Permobil Chairman 2K powered wheelchair

    FDA Recall
    Terminated ·Permobile Inc.·Product code ITI·March 7, 2003

    Osteofil ICM Moldable Strip of varying sizes. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USA***SINGLE PATIENT USE ONLY***''.

    FDA Recall
    Terminated ·Regeneration Technologies, Inc.·Product code MQV·October 14, 2005

    Osteofil RT, ICM Allograft Paste in varying sizes. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USA***SINGLE PATIENT USE ONLY***''.

    FDA Recall
    Terminated ·Regeneration Technologies, Inc.·Product code MQV·October 14, 2005

    Product is REGENAFIL Allograft Paste, Syringe, 0.5cc. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USA***SINGLE PATIENT USE ONLY***''.

    FDA Recall
    Terminated ·Regeneration Technologies, Inc.·Product code MQV·October 14, 2005

    Product is OPTEFIL Allograft Paste of varying sizes. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USA***SINGLE PATIENT USE ONLY***''.

    FDA Recall
    Terminated ·Regeneration Technologies, Inc.·Product code MQV·October 14, 2005

    Osteofil IC Syringeable of varying sizes. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USA***SINGLE PATIENT USE ONLY***''.

    FDA Recall
    Terminated ·Regeneration Technologies, Inc.·Product code MQV·October 14, 2005

    Product is Regenafil IC. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USA***SINGLE PATIENT USE ONLY***''.

    FDA Recall
    Terminated ·Regeneration Technologies, Inc.·Product code MQV·October 14, 2005

    Osteofil Allograft, 5cc. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USA***SINGLE PATIENT USE ONLY***''.

    FDA Recall
    Terminated ·Regeneration Technologies, Inc.·Product code MQV·October 14, 2005

    Product is 2.0 cc Opteform RT. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USA***SINGLE PATIENT USE ONLY***''.

    FDA Recall
    Terminated ·Regeneration Technologies, Inc.·Product code MQV·October 14, 2005

    Product is OPTEFIL Allograft Paste, Syringe of varying sizes. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USA***SINGLE PATIENT USE ONLY***''.

    FDA Recall
    Terminated ·Regeneration Technologies, Inc.·Product code MQV·October 14, 2005

    OSTEOFIL DBM Paste of varying sizes. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USA***SINGLE PATIENT USE ONLY***''.

    FDA Recall
    Terminated ·Regeneration Technologies, Inc.·Product code MQV·October 14, 2005